Dasatinib Side Effects
Medically reviewed by Drugs.com. Last updated on Feb 14, 2022.
Commonly reported side effects of dasatinib include: pericardial effusion, pleural effusion, pulmonary edema, dyspnea, fluid retention, and gastrointestinal hemorrhage. Other side effects include: anasarca. Continue reading for a comprehensive list of adverse effects.
Applies to dasatinib: oral tablets.
Side effects include:
Adverse effects reported in 15% or more of patients receiving dasatinib as monotherapy myelosuppression, fluid retention, diarrhea, headache, rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.
Adverse effects reported in 30% or more of pediatric patients receiving dasatinib in combination with chemotherapy include mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infection, hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.
For Healthcare Professionals
Applies to dasatinib: oral tablet.
In the phase III dose optimization study in patients with chronic phase CML, grade 3 or 4 myelosuppression occurred more frequently in patients treated with the 70 mg twice daily regimen than in those treated with a 100 mg once daily regimen.[Ref]
Very common (10% or more): Hemorrhage (11 to 26%)
Common (1% to 10%): Febrile neutropenia, pancytopenia
Uncommon (0.1% to 1%): CNS bleeding
Rare (Less than 0.1%): Aplasia pure red cell[Ref]
The most common side effects included fluid retention, musculoskeletal pain, diarrhea, rash, and headache.[Ref]
Very common (10% or more): Diarrhea (18 to 31%), vomiting (11 to 16%), nausea (18 to 24%), abdominal pain (12%)
Common (1% to 10%): Enterocolitis infection, gastrointestinal bleeding, neutropenic colitis, gastritis, mucositis, stomatitis, dyspepsia, abdominal distension, constipation, oral soft tissue disorder
Uncommon (0.1% to 1%): Pancreatitis, upper gastrointestinal ulcer, esophagitis, ascites, anal fissure, dysphagia
Rare (Less than 0.1%): Protein-losing gastroenteropathy, ileus
Postmarketing reports: Fatal gastrointestinal hemorrhage[Ref]
Very common (10% or more): Headache (13 to 33%)
Common (1% to 10%): Neuropathy, peripheral neuropathy, dizziness, dysgeusia, somnolence
Uncommon (0.1% to 1%): Syncope, amnesia, tremor
Rare (Less than 0.1%): Cerebrovascular accident, transient ischemic attack, convulsion, optic neuritis, seventh nerve paralysis[Ref]
Very common (10% or more): Musculoskeletal pain (11 to 22%)
Common (1% to 10%): Arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm, chills
Uncommon (0.1% to 1%): Rhabdomyolysis, muscle inflammation, tendonitis, blood creatine phosphokinase increased[Ref]
Very common (10% or more): Pleural effusion (11 to 24%), dyspnea (15 to 24%), cough
Common (1% to 10%): Pneumonia (including bacterial, viral, fungal), upper respiratory tract infection, pulmonary edema, pulmonary hypertension, lung infiltration, pneumonitis
Uncommon (0.1% to 1%): Bronchospasm, asthma
Rare (Less than 0.1%): Acute respiratory distress syndrome
Postmarketing reports: Pulmonary embolism, interstitial lung disease, pulmonary arterial hypertension[Ref]
Common (1% to 10%): Anorexia, appetite disturbances, hyperuricemia, weight decreased, weight increased
Uncommon (0.1% to 1%): Hypoalbuminemia[Ref]
Uncommon (0.1% to 1%): Hepatitis, cholecystitis, cholestasis[Ref]
Results from phase II single arm clinical studies of 911 patients reported QT prolongation in 9 patients. Three patients (less than 1%) experienced a QTcF greater than 500 milliseconds.
In the phase III dose optimization study in patients with chronic phase CML, pleural effusion and congestive cardiac failure/cardiac dysfunction occurred more frequently in the 70 mg twice a day regimen than in those treated with a 100 mg once daily regimen.[Ref]
Common (1% to 10%): Congestive heart failure, cardiac dysfunction, pericardial effusion, arrhythmia, tachycardia, palpitations, hypertension, chest pain
Uncommon (0.1% to 1%): Myocardial infarction, electrocardiogram QT prolongation, pericarditis, ventricular arrhythmia, ventricular tachycardia, angina pectoris, cardiomegaly, hypotension
Rare (less than 0.1%): Cor pulmonale, myocarditis, acute coronary syndrome
Postmarketing reports: Atrial fibrillation, atrial flutter[Ref]
Very common (10% or more): Skin rash (15 to 21%)
Common (1% to 10%): Flushing, alopecia, dermatitis, eczema, pruritus, acne, dry skin, urticaria, hyperhidrosis, contusion
Uncommon (0.1% to 1%): Acute febrile neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome
Rare (Less than 0.1%): Livedo reticularis[Ref]
Very common (10% or more): Fluid retention (21 to 42%)
Uncommon (0.1% to 1%): Renal failure, urinary frequency, proteinuria[Ref]
Very common (10% or more): Fatigue (19 to 26%), superficial edema (10 to 21%), pyrexia (11 to 18%)
Common (1% to 10%): Tinnitus, pain, generalized edema, asthenia
Uncommon (0.1% to 10%): Vertigo, thrombophlebitis, gynecomastia, irregular menstruation, malaise, temperature intolerance
Postmarketing reports: Deep vein thrombosis[Ref]
Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Anxiety, confusion, affect lability, libido decreased[Ref]
Uncommon (0.1% to 1%): Erythema nodosum, unspecified hypersensitivity reaction[Ref]
Common (1% to 10%): Visual disturbance, blurred vision, reduction in visual acuity, dry eye
Uncommon (0.1% to 1%): Conjunctivitis
Rare (Less than 0.1%): Visual impairment[Ref]
Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]
Very common (10% or more): Infection (including bacterial, viral, fungal, non-specified) (10 to 14%)
Common (1% to 10%): Sepsis[Ref]
Frequently asked questions
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Related treatment guides
1. Product Information. Sprycel (dasatinib). Bristol-Myers Squibb. 2006.
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Some side effects may not be reported. You may report them to the FDA.